BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1133344 · Received August 22, 2008

    Report

    Report Number
    2024168-2008-00703
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 25, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION: DISSECTION IS LISTED IN THE IFU AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. THIS KNOWN PT EFFECT IS NOT NECESSARILY AN INDICATION OF PROD QUALITY ISSUE. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. THE IFU ALSO CAUTIONS THAT "IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADD'L INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADD'L STENT, OR OTHER)". A CONCLUSIVE ROOT CAUSE FOR THE REPORTED EVENT AND THE RELATIONSHIP TO THE DEVICE IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE. DEVICE ISSUE: NONE. IT WAS REPORTED THAT DURING THE USE OF THE XIENCE V STENT DELIVERY SYSTEM (SDS) A DISSECTION OCCURRED. ANOTHER XIENCE V SDS WAS USED TO TREAT THE DISSECTION. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8010861

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention STENT: XIENCE V 2.5 X 18 MM| DIL CATH: VOYAGER| GUIDE CATH: EBU| GUIDE WIRE: BMW